NDC 36987-3257

Rough Marsh Elder

Rough Marsh Elder

Rough Marsh Elder is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Nelco Laboratories, Inc.. The primary component is Iva Annua Var. Annua Pollen.

• Product ID: 36987-3257_39113b10-fd1f-4cfc-8432-755a1686fcc4
• NDC: 36987-3257
• Product Type: Human Prescription Drug
• Proprietary Name: Rough Marsh Elder
• Generic Name: Rough Marsh Elder
• Dosage Form: Injection, Solution
• Route of Administration: INTRADERMAL; SUBCUTANEOUS
• Marketing Start Date: 1972-08-29
• Marketing Category: BLA / BLA
• Application Number: BLA102192
• Labeler Name: Nelco Laboratories, Inc.
• Substance Name: IVA ANNUA VAR. ANNUA POLLEN
• Active Ingredient Strength: 40000 [PNU]/mL
• Pharm Classes: Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 36987-3257-2

10 mL in 1 VIAL, MULTI-DOSE (36987-3257-2)

• Marketing Start Date: 1972-08-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36987-3257-2 [36987325702]

Rough Marsh Elder INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102192
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1972-08-29
• Inactivation Date: 2019-10-21

NDC 36987-3257-1 [36987325701]

Rough Marsh Elder INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102192
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1972-08-29
• Inactivation Date: 2019-10-21

NDC 36987-3257-3 [36987325703]

Rough Marsh Elder INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102192
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1972-08-29
• Inactivation Date: 2019-10-21

NDC 36987-3257-4 [36987325704]

Rough Marsh Elder INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102192
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1972-08-29
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
IVA ANNUA VAR. ANNUA POLLEN	40000 [PNU]/mL

OpenFDA Data

• SPL SET ID: a63e5aef-44c2-4f90-a33d-91ec10298089
• Manufacturer:
  • Nelco Laboratories, Inc.
• UNII:
  • U2AI3H2J5Y
  • 92N6W6KO2G
  • 2A64U81OQ3
  • 68R9X9Y96X
  • 098LKX5NCN
  • 380W4HYR6N
  • YB1308W43O
  • 644CZ16IR5
  • BBO1IJ3ZIW
  • DO87T1U2CI
  • YI19RB8YFD
  • JQ87AA60GU
  • 6532U64A3X
  • 81GS97HVFO
  • RX18M46K8L
  • 86LWA5503I
  • 2MH135KC6G
  • 5W6JAI84OI
  • V825XJG64G
  • 1GH3WV23KH
  • 2QOF601J1M
  • WIB701MW2H
  • WQ3S5294XY
  • N52MIQ81ZW
  • O4AB4546TP
  • DNB59M1NVU
  • 26U0BU8G83
  • B67NF86HF0
  • 57KIJ4772H
  • ANT994T71D
  • KU1V1898XX
  • 13KFG30UBR
  • 73B14PX5FW
• RxNorm Concept Unique ID - RxCUI:
  • 897968
  • 896133
  • 897315
  • 896281
  • 1006367
  • 895914
  • 895614
  • 896290
  • 1006488
  • 895679
  • 896265
  • 897977
  • 896302
  • 896080
  • 897402
  • 1013974
  • 897959
  • 897951
  • 896198
  • 897998
  • 901477
  • 896173
  • 896158
  • 1006359
  • 897376
  • 897327
  • 1013976
  • 896211
  • 895728
  • 897343
  • 897533
  • 898339
  • 896114
  • 896257
  • 901495
  • 897384
  • 1013991

Pharmacological Class

• Non-Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]

NDC Crossover Matching brand name "Rough Marsh Elder" or generic name "Rough Marsh Elder"

NDC	Brand Name	Generic Name
36987-3253	Rough Marsh Elder	Rough Marsh Elder
36987-3254	Rough Marsh Elder	Rough Marsh Elder
36987-3255	Rough Marsh Elder	Rough Marsh Elder
36987-3256	Rough Marsh Elder	Rough Marsh Elder
36987-3257	Rough Marsh Elder	Rough Marsh Elder
36987-3258	Rough Marsh Elder	Rough Marsh Elder
36987-3259	Rough Marsh Elder	Rough Marsh Elder
36987-3260	Rough Marsh Elder	Rough Marsh Elder
49288-0270	Rough Marsh Elder	Rough Marsh Elder
49288-0271	Rough Marsh Elder	Rough Marsh Elder